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IP News

By Joshua R. Stein and Jeffrey S. Ginsberg
January 01, 2022

Pair of Federal Circuit Decisions Address Standing to Appeal Adverse IPR Decision

In 2018 and 2019, ModernaTx, Inc. (Moderna) filed a pair of inter partes review petitions challenging the validity of two patents generally directed to RNA technology owned by Arbutus Biopharma Corp. (Arbutus). The Patent Trial and Appeal Board (PTAB) held that certain challenged claims of each patent were not unpatentable. On Dec. 1, 2021, a Federal Circuit panel of Judges Lourie, O'Malley, and Stoll issued two opinions, each authored by Judge Lourie and captioned ModernaTx, Inc. v. Arbutus Biopharma Corp., Nos. 2020-1184, -1186 (Fed. Cir. Dec. 1, 2021) (Moderna I) and No. 2020-2329 (Moderna II), holding that Moderna had standing to appeal only one of the two adverse decisions by the PTAB and otherwise affirming the PTAB's findings on appeal and cross-appeal.

Factual Background

The cases concern two related patents — U.S. Patent Nos. 8,058,069 (the '069 patent) and 9,364,435 (the '435 patent) — that are each entitled "lipid formulations for nucleic acid delivery" and are generally directed to "stable nucleic acid-lipid particles (SNALP) comprising a nucleic acid (such as one or more interfering RNA), methods of making the SNALP, and methods of delivering and/or administering the SNALP." '069 patent, Abstract.

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